Interventional procedure overview of prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia

Efficacy summary

Symptom improvement

In a randomised controlled trial of 185 patients, 79% who had a prostatic temporary implant insertion and 60% who had a sham procedure had an improvement in IPSS of 3.0 points or more at 3 months compared with baseline (p=0.029) in the intention-to-treat population. The mean improvement in IPSS was 9.0 points in the implant group and 6.6 points in the control group (p=0.063). At 12 months, the mean change in IPSS urinary symptoms score in patients who had a temporary implant inserted (per-protocol population) was -9.25 (95% CI ‑11.0 to ‑7.4, p<0.0001). The mean change in IIEF score was 4.5 (95% CI 0.2 to 8.8, p=0.01; Chughtai, 2021).

In a single-arm trial of 81 patients, the mean reduction in IPSS score in the intention-to-treat population was 9.2 at 4 weeks, 11.1 at 6 months, 11.2 at 12 months, 10.1 at 24 months and 10.3 at 36 months (p<0.0001 for all periods; Amparore, 2021).

In a single-arm trial of 70 patients, the mean change in IPSS urinary symptoms score was ‑11.7 at 4 weeks, ‑13.4 at 3 months and -12.7 at 6 months (p<0.01 for all periods). The Incontinence Symptom Index questionnaire total score changed by -0.5 at 4 weeks (p=0.21), and by -0.3 at 3 and 6 months (p=0.14; De Nunzio, 2020).

In a single-arm trial of 32 patients, the mean IPSS reduced by 39% at 3 weeks, 47% at 6 months, 45% at 1 year, 23% at 2 years and 19% at 3 years (p<0.001; Porpiglia, 2018).

Quality of life

In the randomised controlled trial of 185 patients, at 3 months, the mean IPSS quality-of-life score improved from 4.6 to 2.7 in the implant group and from 4.9 to 3.4 in the control group (p=0.264) in the intention-to-treat population. At 12 months, the mean change in IPSS quality-of-life score in patients who had a temporary implant inserted (per-protocol population) was -1.90 (95% CI -2.2 to ‑1.4, p<0.0001; Chughtai, 2021).

In the single-arm trial of 81 patients, the mean improvement in IPSS quality-of-life score was -1.68 at 4 weeks, -1.93 at 6 months, -2.06 at 12 months, -1.77 at 24 months and -1.78 at 36 months in the intention-to-treat population (p<0.0001 for all periods; Amparore, 2021).

In the single-arm trial of 70 patients, the mean change in IPSS quality-of-life score was -2.4 at 4 weeks, -2.5 at 3 months and -2.2 at 6 months (p<0.01 for all periods; De Nunzio, 2020).

In the single-arm trial of 32 patients, the median quality-of-life score was 2 at 24 and 36 months compared with 3 at baseline (Porpiglia, 2018).

Peak urinary flow rate

In the randomised controlled trial of 185 patients, at 3 months, the mean peak urinary flow rate improved from 8.7 ml/second to 13.1 ml/second in the implant group and from 8.5 ml/second to 11.4 ml/second in the control group (p=0.230) in the intention-to-treat population. At 12 months, the increase in peak urinary flow in patients who had a temporary implant inserted (per-protocol population) was 3.52 ml/second (95% CI 2.0 to 5.0, p<0.0001; Chughtai, 2021).

In the single-arm trial of 81 patients, the mean improvement in peak urinary flow rate was 4.63 ml/second at 4 weeks, 5.28 ml/second at 6 months, 5.97 ml/second at 12 months, 6.82 ml/second at 24 months and 6.15 ml/second 36 months in the intention-to-treat population (p<0.0001 for all periods; Amparore, 2021).

In the single-arm trial of 70 patients, the mean change in peak urinary flow rate was 5.8 ml/second at 4 weeks, 4.5 ml/second at 3 months and 4.6 ml/second at 6 months (p<0.01 for all periods; De Nunzio, 2020).

In the single-arm trial of 32 patients, the mean peak urinary flow increased by 37% at 3 weeks, 61% at 6 months, 67% at 1 year, 54% at 2 years and 41% at 3 years (p<0.001; Porpiglia, 2018).

PVR volume

In the randomised controlled trial of 185 patients, at 3 months, the mean PVR volume decreased from 60.8 ml to 59.4 ml in the implant group and increased from 61.9 ml to 66.9 ml in the control group (p=0.781) in the intention-to-treat population. At 12 months, the mean change in PVR volume in patients who had a temporary implant inserted (per-protocol population) was -0.16 ml (95% CI -24.6 to 24.3, p=0.9039; Chughtai, 2021).

In the single-arm trial of 81 patients, the mean change in postvoid volume was ‑21.44 ml at 4 weeks, -21.54 ml at 6 months, -27.69 ml at 12 months, -32.86 ml at 24 months and -36.11 ml at 36 months in the intention-to-treat population (p<0.001 for all periods; Amparore, 2021).

In the single-arm trial of 70 patients, the mean change in PVR volume was ‑19. ml at 4 weeks, -37.4 ml at 3 months and -22.6 ml at 6 months (p=0.13, 0.11 and 0.12; De Nunzio, 2020).

Sexual function

In the randomised controlled trial of 185 patients, the mean SHIM score improved by 0.45 points after 12 months (95% CI -1.0 to 1.9, p=0.3155) in patients who had a temporary implant inserted (per-protocol population). Results were not reported for the control arm (Chughtai, 2021).

In the single-arm trial of 70 patients, the mean improvement in ejaculatory function score on the Male Sexual Health Questionnaire was 1.5 at 4 weeks, 1.8 at 3 months and 2.0 at 6 months (p<0.01 for all periods). The SHIM score improved by 1.9 at 4 weeks, 2.3 at 3 months and 2.2 at 6 months (p=0.09, 0.07, 0.06; De Nunzio, 2020).

Need for medication

In the single-arm trial of 32 patients, all patients were able to stop LUTS-related medical therapy 3 months after the implantation. However, 3 patients (9%) needed it again within 12 or 24 months of treatment (Porpiglia, 2018).

Patient satisfaction

In the single-arm trial of 32 patients, the median Expanded Prostate Cancer Index Composite question 32 score was 5 (corresponding to extremely satisfied) throughout follow up. The differences at different time points were not statistically significant (p=0.180; Porpiglia, 2018).